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1 What You Should NOAC About the New Anticoagulants Dr Calum Young Cardiologist

2 Overview The Burden of AF What s Wrong With Warfarin? The Era of NOACs NOACs in New Zealand Clinical Trials with NOACs Potential issues NOACs- including the Media The Future

3 The Burden of AF Overall prevalence in population is at least 1%, but rises with age (>10% of 80 year olds) Common incidental finding Management: Symptom control (rate versus rhythm control) Risk reduction Stroke Rate-related cardiomyopathy

18 NOACs in NZ CARM received 345 reports of adverse reactions to dabigatran in the first three months A quarter involved prescriber error Up to a third of patients experience transient, or ongoing, dyspepsia (likely related to the tartaric acid in the dabigatran formulation)

19 NOACs in NZ In March 2013, CARM reported three NZ cases of blood clots in mechanical valve patients using dabigatran (off label) RE-ALIGN study (published NEJM, September 2013) was terminated early after studying 252 mechanical valve patients randomised to warfarin or dabigatran- due to excess risk with dabigatran

20 NOACs in NZ Patients with mechanical heart valves (or severe underlying native valve issuesespecially mitral stenosis) should NOT be treated with NOACs Warfarin is the only suitable agent in this group of patients Patients with bioprosthetic valves and AF can be treated with NOACs

34 Cumulative Rates of the Primary End Point (Stroke or Systemic Embolism) in the Per- Protocol Population and in the Intention-to-Treat Population. ROCKET-AF, 2011 Patel MR et al. N Engl J Med 2011;365:

37 Other Advantages for NOACs Quick spontaneous offset of action No prolonged time off agent required prior to elective surgery, and therefore less likelihood of requiring bridging therapy with heparin/ LMWH Is a definite rebound effect for strokes when stopping oral anti-coagulants Prompt onset of action on re-commencement Avoidance of post-operative heparin/ LMWH

38 Switching to NOACs If patient is on warfarin, wait until INR is <2.0 before commencing NOAC Bridging therapy with heparin/ LMWH should not generally be required

53 Thienopyridine Anti-Platelet Agents Generally these are used as an adjunct to aspirin after cardiac events (MI) or coronary intervention (especially PCI/stenting) The most common agent is the thienopyridine, ADP-receptor blocker clopidogrel It s predecessor, ticlopidine, was associated with higher rates of thrombocytopaenia

54 Thienopyridine Anti-Platelet Clopidogrel: Agents Generally given for at least a month post coronary stenting Up to 12 months, particularly if drug-eluting stent Also given often for 3 months after a medicallytreated MI, and for 1-3 months post bypass surgery (CABG)

64 Question One: Which patient with atrial fibrillation would be the best potential candidate for dabigatran? a. 78 year old male with a mechanical mitral valve replacement b. 38 year old female with severe mitral stenosis c. 82 year old male with a bioprosthetic mitral valve replacement d. 72 year old female with a creatinine clearance of 18 e. 42 year old male with mechanical aortic valve replacement

65 Question Two: What statement is true? a. Apixaban is available for selected public Cardiology patients via an early access programme b. Rivaroxaban is given once daily c. Edoxaban is widely available overseas but not yet in New Zealand d. Overseas regulatory authorities have recommended avoiding commencing new patients on dabigatran pending new safety data e. Warfarin is safer than the new anticoagulant agents because it can be reversed by Vitamin K

66 Question Two: What statement is true? a. Apixaban is available for selected public Cardiology patients via an early access programme b. Rivaroxaban is given once daily c. Edoxaban is widely available overseas but not yet in New Zealand d. Overseas regulatory authorities have recommended avoiding commencing new patients on dabigatran pending new safety data e. Warfarin is safer than the new anticoagulant agents because it can be reversed by Vitamin K

67 Question Three: What statement is true? a. An INR level gives a good indication of plasma dabigatran levels b. Vitamin K can help reverse the effects of dabigatran c. Prior to elective surgery, dabigatran should be withheld for a week prior to the operation date d. When restarting dabigatran after surgery, subcutaneous low-molecular weight heparin should be given as bridging therapy for 3 days e. The half-life of dabigatran is hours

69 Question Five: What statement is true? a. Apixaban is a direct thrombin inhibitor b. Patients on dabigatran can choose to open the capsules and take the contents in a glass of water if that is easier for them c. Rivaroxaban cannot be packaged in blister packaging d. An antidote for dabigatran under development is a Fab-binding agent, and may be available as soon as 2015 e. You can switch a patient from warfarin to dabigatran as soon as the INR is less than 3.0

70 Question Six: What statement is true? a. All thienopyridines bind to the same ADP receptor b. Ticagrelor has a more prolonged action than the other thienopyridines c. Prasugrel is available on Special Authority in NZ for clopidogrel-allergic patients post coronary angioplasty d. Prasugrel has a much lower bleeding risk than clopidogrel e. Shorter courses of dual anti-platelet therapy can be used in patients with drug-eluting stents

71 Quiz Answers

72 Question One: Which patient with atrial fibrillation would be the best potential candidate for dabigatran? a. 78 year old male with a mechanical mitral valve replacement b. 38 year old female with severe mitral stenosis c. 82 year old male with a bioprosthetic mitral valve replacement d. 72 year old female with a creatinine clearance of 18 e. 42 year old male with mechanical aortic valve replacement

73 Question Two: What statement is true? a. Apixaban is available for selected public Cardiology patients via an early access programme b. Rivaroxaban is given once daily c. Edoxaban is widely available overseas but not yet in New Zealand d. Overseas regulatory authorities have recommended avoiding commencing new patients on dabigatran pending new safety data e. Warfarin is safer than the new anticoagulant agents because it can be reversed by Vitamin K

74 Question Three: What statement is true? a. An INR level gives a good indication of plasma dabigatran levels b. Vitamin K can help reverse the effects of dabigatran c. Prior to elective surgery, dabigatran should be withheld for a week prior to the operation date d. When restarting dabigatran after surgery, subcutaneous low-molecular weight heparin should be given as bridging therapy for 3 days e. The half-life of dabigatran is hours

76 Question Five: What statement is true? a. Apixaban is a direct thrombin inhibitor b. Patients on dabigatran can choose to open the capsules and take the contents in a glass of water if that is easier for them c. Rivaroxaban cannot be packaged in blister packaging d. An antidote for dabigatran under development is a Fab-binding agent, and may be available as soon as 2015 e. You can switch a patient from warfarin to dabigatran as soon as the INR is less than 3.0

77 Question Six: What statement is true? a. All thienopyridines bind to the same ADP receptor b. Ticagrelor has a more prolonged action than the other thienopyridines c. Prasugrel is available on Special Authority in NZ for clopidogrel-allergic patients post coronary angioplasty d. Prasugrel has a much lower bleeding risk than clopidogrel e. Shorter courses of dual anti-platelet therapy can be used in patients with drug-eluting stents

78 Summary Current studies indicate that NOACs have a net benefit over warfarin Lower strokes Lower bleeding risk The lack of reversal agent for NOACs should be part of the routine patient discussion, but the issue is not necessarily straightforward Supportive therapies etc

STROKE PREVENTION IN ATRIAL FIBRILLATION OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention of ischemic stroke and arterial thromboembolism in patients

Antiplatelet and Antithrombotics From clinical trials to guidelines Ashraf Reda, MD, FESC Prof and head of Cardiology Dep. Menofiya University Preisedent of EGYBAC Chairman of WGLVR One of the big stories

COMPARISON OF NEW ORAL ANTICOAGULANTS AND FREQUENTLY- ASKED QUESTIONS FROM PATIENTS AND PHYSICIANS TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVES: To provide a comparison of the new

Non- Valvular Atrial Fibrillation and Stroke Prevention: Which OAC Do I Choose Warfarin vs the NOACs Dr. Lori McIntosh D.O. Board Certified Neurologist Objectives Be able to list the current options of

Dabigatran (Pradaxa) Guidelines Dabigatran is a new anticoagulant for reducing the risk of stroke in patients with atrial fibrillation. Dabigatran is a direct thrombin inhibitor, similar to warfarin, without

The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012 Jeff Healey RELY: A New Era in AF Connolly SJ et al. N Engl J Med 2009;361:1139-1151 ROCKET-AF:

This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics

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Dabigatran revisited 22 Dabigatran has been available for general practitioners to prescribe since July, 2011. Twelve months later, over 14 000 patients were being dispensed this medicine. Dabigatran is

Disclosures The New Oral Anticoagulants: Are they better than Warfarin? Alan P. Agins, Ph.D. does not have any actual or potential conflicts of interest in relation to this CE activity. Alan Agins, Ph.D.

Cardiovascular Subcommittee of PTAC Meeting held 27 February 2014 (minutes for web publishing) Cardiovascular Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology

TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University

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NOACS AND AF PEARLS AND PITFALLS DR LAURA YOUNG HAEMATOLOGIST NGAIRE IS 70 YEARS OLD AND IN AF. SHE HAS NO MURMURS, NORMAL BLOOD PRESSURE, EGFR OF 65ML/MIN AND NO SIGNIFICANT PAST MEDICAL HISTORY. REGARDING

Leeds Dabigatran: Amber Drug Guidance for the prevention of stroke and systemic embolism in patients with non-valvular AF Amber Drug Level 3 (amber drug with monitoring requirements) We have started your

Title of Guideline Contact Name and Job Title (author) Guideline for patients receiving Dabigatran (Pradaxa ) requiring Emergency Surgery or treatment for Haemorrhage Julian Holmes (Haemostasis and Thrombosis

Anticoagulation: How Do I Pick From All the Choices? Jeffrey H. Neuhauser, DO, FACC BHHI Primary Care Symposium February 28, 2014 Atrial Fibrillation 2 Atrial Fibrillation The most common arrhythmia encountered

Title of Guideline Contact Name and Job Title (author) Guideline for patients receiving Rivaroxaban (Xarelto ) requiring Emergency Surgery or treatment for Haemorrhage Julian Holmes (Haemostasis and Thrombosis

MEDICAL ASSISTANCE HBOOK I. Requirements for Prior Authorization of Anticoagulants A. Prescriptions That Require Prior Authorization Prescriptions for Anticoagulants which meet any of the following conditions